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Trial record 1 of 1 for:    QHD00011
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Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04024228
Recruitment Status : Completed
First Posted : July 18, 2019
Results First Posted : January 19, 2021
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza (Healthy Volunteers)
Interventions Biological: Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD)
Biological: High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation
Enrollment 1539
Recruitment Details The study was conducted at 17 active centers in 6 countries. A total of 1539 participants were enrolled and randomized between 28 October 2019 to 15 November 2019.
Pre-assignment Details A total of 1533 participants were vaccinated in the study.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0.
Period Title: Overall Study
Started [1] 774 765
Vaccinated 772 761
Full Analysis Set (FAS) [2] 769 [3] 758 [4]
Completed 770 759
Not Completed 4 6
Reason Not Completed
Adverse Event             1             0
Protocol Deviation             0             2
Withdrawal by Subject             3             4
[1]
Randomized
[2]
FAS included all randomized participants who received the study vaccine and had a post-vaccination blood sample.
[3]
377 participants (60-64 years) and 392 participants (>=65 years).
[4]
377 participants (60-64 years) and 381 participants (>=65 years).
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD Total
Hide Arm/Group Description Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 774 765 1539
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 774 participants 765 participants 1539 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
379
  49.0%
381
  49.8%
760
  49.4%
>=65 years
395
  51.0%
384
  50.2%
779
  50.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 774 participants 765 participants 1539 participants
66.6  (5.82) 66.6  (6.11) 66.6  (5.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 774 participants 765 participants 1539 participants
Female
385
  49.7%
390
  51.0%
775
  50.4%
Male
389
  50.3%
375
  49.0%
764
  49.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 774 participants 765 participants 1539 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   0.5%
3
   0.4%
7
   0.5%
Native Hawaiian or Other Pacific Islander
4
   0.5%
2
   0.3%
6
   0.4%
Black or African American
2
   0.3%
2
   0.3%
4
   0.3%
White
758
  97.9%
756
  98.8%
1514
  98.4%
More than one race
0
   0.0%
1
   0.1%
1
   0.1%
Unknown or Not Reported
6
   0.8%
1
   0.1%
7
   0.5%
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years
Hide Description GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
Overall Number of Participants Analyzed 769 758
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
A/H1N1: Day 28: 60-64 years Number Analyzed 377 participants 377 participants
471
(416 to 533)
248
(217 to 283)
A/H3N2: Day 28: 60-64 years Number Analyzed 376 participants 377 participants
303
(262 to 350)
178
(154 to 206)
B1: Day 28: 60-64 years Number Analyzed 377 participants 377 participants
497
(450 to 548)
330
(297 to 367)
B2: Day 28: 60-64 years Number Analyzed 377 participants 377 participants
766
(690 to 849)
433
(391 to 480)
A/H1N1: Day 28: >= 65 years Number Analyzed 392 participants 381 participants
286
(250 to 326)
162
(139 to 190)
A/H3N2: Day 28: >=65 years Number Analyzed 392 participants 381 participants
324
(281 to 374)
151
(129 to 176)
B1: Day 28: >=65 years Number Analyzed 392 participants 381 participants
405
(366 to 447)
262
(236 to 291)
B2: Day 28: >=65 years Number Analyzed 392 participants 381 participants
536
(485 to 592)
305
(274 to 340)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: QIV-HD, Group 2: QIV-SD
Comments A/H1N1: 60-64 years
Type of Statistical Test Superiority
Comments Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was above 1 between groups for each of the comparisons.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.90
Confidence Interval (2-Sided) 95%
1.58 to 2.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1: QIV-HD, Group 2: QIV-SD
Comments A/H3N2: 60-64 years
Type of Statistical Test Superiority
Comments Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
1.38 to 2.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1: QIV-HD, Group 2: QIV-SD
Comments B1: 60-64 years
Type of Statistical Test Superiority
Comments Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.30 to 1.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1: QIV-HD, Group 2: QIV-SD
Comments B2: 60-64 years
Type of Statistical Test Superiority
Comments Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.77
Confidence Interval (2-Sided) 95%
1.53 to 2.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group 1: QIV-HD, Group 2: QIV-SD
Comments A/H1N1: >=65 years
Type of Statistical Test Superiority
Comments Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.44 to 2.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group 1: QIV-HD, Group 2: QIV-SD
Comments A/H3N2: >=65 years
Type of Statistical Test Superiority
Comments Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 2.15
Confidence Interval (2-Sided) 95%
1.74 to 2.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Group 1: QIV-HD, Group 2: QIV-SD
Comments B1: >=65 years
Type of Statistical Test Superiority
Comments Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
1.34 to 1.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Group 1: QIV-HD, Group 2: QIV-SD
Comments B2: >=65 years
Type of Statistical Test Superiority
Comments Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.52 to 2.03
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants
Hide Description GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.
Time Frame Day 0 (pre-vaccination), Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 769 758
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
A/H1N1: Day 0 Number Analyzed 768 participants 758 participants
48.6
(43.4 to 54.4)
46.2
(41.4 to 51.7)
A/H1N1: Day 28 Number Analyzed 769 participants 758 participants
365
(333 to 400)
200
(181 to 222)
A/H3N2: Day 0 Number Analyzed 767 participants 757 participants
13.3
(12.3 to 14.4)
13.0
(12.0 to 14.1)
A/H3N2: Day 28 Number Analyzed 768 participants 758 participants
313
(283 to 347)
164
(148 to 182)
B1: Day 0 Number Analyzed 767 participants 757 participants
63.9
(57.7 to 70.7)
74.5
(67.3 to 82.4)
B1: Day 28 Number Analyzed 769 participants 758 participants
447
(417 to 480)
294
(272 to 316)
B2: Day 0 Number Analyzed 765 participants 755 participants
89.7
(80.5 to 99.9)
96.6
(86.9 to 107)
B2: Day 28 Number Analyzed 769 participants 758 participants
638
(594 to 686)
363
(337 to 392)
3.Secondary Outcome
Title Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years
Hide Description GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.
Time Frame Day 0 (pre-vaccination), Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 769 758
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
A/H1N1: Day 0: 60-64 Years Number Analyzed 376 participants 377 participants
50.2
(42.7 to 59.0)
50.0
(42.6 to 58.8)
A/H1N1: Day 28: 60-64 Years Number Analyzed 377 participants 377 participants
471
(416 to 533)
248
(217 to 283)
A/H3N2: Day 0: 60-64 Years Number Analyzed 376 participants 377 participants
11.5
(10.4 to 12.8)
12.5
(11.2 to 14.0)
A/H3N2: Day 28: 60-64 Years Number Analyzed 376 participants 377 participants
303
(262 to 350)
178
(154 to 206)
B1: Day 0: 60-64 Years Number Analyzed 377 participants 377 participants
54.7
(47.4 to 63.2)
68.7
(59.4 to 79.5)
B1: Day 28: 60-64 Years Number Analyzed 377 participants 377 participants
497
(450 to 548)
330
(297 to 367)
B2: Day 0: 60-64 Years Number Analyzed 377 participants 375 participants
80.4
(68.6 to 94.3)
93.2
(79.5 to 109)
B2: Day 28: 60-64 Years Number Analyzed 377 participants 377 participants
766
(690 to 849)
433
(391 to 480)
A/H1N1: Day 0: >=65 Years Number Analyzed 392 participants 381 participants
47.1
(40.1 to 55.2)
42.8
(36.6 to 50.0)
A/H1N1: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
286
(250 to 326)
162
(139 to 190)
A/H3N2: Day 0: >=65 Years Number Analyzed 391 participants 380 participants
15.2
(13.5 to 17.1)
13.5
(12.1 to 15.0)
A/H3N2: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
324
(281 to 374)
151
(129 to 176)
B1: Day 0: >=65 Years Number Analyzed 390 participants 380 participants
74.2
(64.3 to 85.6)
80.7
(70.1 to 92.9)
B1: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
405
(366 to 447)
262
(236 to 291)
B2: Day 0: >=65 Years Number Analyzed 388 participants 380 participants
99.7
(86.1 to 115)
100
(86.8 to 115)
B2: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
536
(485 to 592)
305
(274 to 340)
4.Secondary Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants
Hide Description GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Time Frame Day 0 (pre-vaccination), Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 769 758
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1: Day 28/Day 0 Number Analyzed 768 participants 758 participants
7.50
(6.68 to 8.42)
4.34
(3.88 to 4.84)
A/H3N2: Day 28/Day 0 Number Analyzed 767 participants 757 participants
23.7
(21.4 to 26.1)
12.6
(11.3 to 14.0)
B1: Day 28/Day 0 Number Analyzed 767 participants 757 participants
7.02
(6.34 to 7.77)
3.95
(3.56 to 4.38)
B2: Day 28/Day 0 Number Analyzed 765 participants 755 participants
7.13
(6.44 to 7.90)
3.77
(3.42 to 4.15)
5.Secondary Outcome
Title Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years
Hide Description GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Time Frame Day 0 (pre-vaccination), Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 769 758
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1: Day 28/Day 0: 60-64 Years Number Analyzed 376 participants 377 participants
9.36
(7.86 to 11.1)
4.96
(4.20 to 5.85)
A/H3N2: Day 28/Day 0: 60-64 Years Number Analyzed 376 participants 377 participants
26.2
(22.8 to 30.2)
14.2
(12.2 to 16.6)
B1: Day 28/Day 0: 60-64 Years Number Analyzed 377 participants 377 participants
9.07
(7.84 to 10.5)
4.80
(4.11 to 5.60)
B2: Day 28/Day 0: 60-64 Years Number Analyzed 377 participants 375 participants
9.52
(8.19 to 11.1)
4.66
(4.03 to 5.39)
A/H1N1: Day 28/Day 0: >=65 Years Number Analyzed 392 participants 381 participants
6.07
(5.22 to 7.05)
3.80
(3.27 to 4.41)
A/H3N2: Day 28/Day 0: >=65 Years Number Analyzed 391 participants 380 participants
21.4
(18.6 to 24.7)
11.2
(9.66 to 13.0)
B1: Day 28/Day 0: >=65 Years Number Analyzed 390 participants 380 participants
5.48
(4.78 to 6.28)
3.25
(2.83 to 3.73)
B2: Day 28/Day 0: >=65 Years Number Analyzed 388 participants 380 participants
5.39
(4.72 to 6.15)
3.06
(2.70 to 3.46)
6.Secondary Outcome
Title Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution)
Hide Description Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (all age group participants) with neutralizing antibody titers >=40 (1/dilution) is reported in the outcome measure.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 769 758
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Day 28 Number Analyzed 769 participants 758 participants
96.6
(95.1 to 97.8)
88.4
(85.9 to 90.6)
A/H3N2: Day 28 Number Analyzed 768 participants 758 participants
93.8
(91.8 to 95.4)
86.4
(83.8 to 88.8)
B1: Day 28 Number Analyzed 769 participants 758 participants
99.5
(98.7 to 99.9)
99.2
(98.3 to 99.7)
B2: Day 28 Number Analyzed 769 participants 758 participants
99.5
(98.7 to 99.9)
98.3
(97.1 to 99.1)
7.Secondary Outcome
Title Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution)
Hide Description Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (aged 60-64 Years and >=65 Years) with neutralizing antibody titers >=40 (1/dilution) is reported in the outcome measure.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 769 758
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Day 28: 60-64 Years Number Analyzed 377 participants 377 participants
98.1
(96.2 to 99.3)
92.3
(89.1 to 94.8)
A/H3N2: Day 28: 60-64 Years Number Analyzed 376 participants 377 participants
94.9
(92.2 to 96.9)
89.1
(85.5 to 92.1)
B1: Day 28: 60-64 Years Number Analyzed 377 participants 377 participants
100
(99.0 to 100)
99.5
(98.1 to 99.9)
B2: Day 28: 60-64 Years Number Analyzed 377 participants 377 participants
99.7
(98.5 to 100)
99.5
(98.1 to 99.9)
A/H1N1: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
95.2
(92.5 to 97.1)
84.5
(80.5 to 88.0)
A/H3N2: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
92.6
(89.5 to 95.0)
83.7
(79.6 to 87.3)
B1: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
99.0
(97.4 to 99.7)
99.0
(97.3 to 99.7)
B2: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
99.2
(97.8 to 99.8)
97.1
(94.9 to 98.6)
8.Secondary Outcome
Title Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens
Hide Description Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (<) 1:10 (1/dilution) and a post-vaccination titer >=1:40 (1/dilution) or a pre-vaccination titer >= 1:10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (all age group participants) achieving seroconversion is reported in the outcome measure.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 769 758
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Day 28 Number Analyzed 768 participants 758 participants
62.1
(58.6 to 65.6)
39.2
(35.7 to 42.8)
A/H3N2: Day 28 Number Analyzed 767 participants 757 participants
88.1
(85.6 to 90.3)
74.2
(71.0 to 77.3)
B1: Day 28 Number Analyzed 767 participants 757 participants
62.5
(58.9 to 65.9)
41.2
(37.7 to 44.8)
B2: Day 28 Number Analyzed 765 participants 755 participants
62.7
(59.2 to 66.2)
41.6
(38.0 to 45.2)
9.Secondary Outcome
Title Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens
Hide Description Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 (1/dilution) and a post-vaccination titer >= 1:40 (1/dilution) or a pre-vaccination titer >= 1:10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (aged 60-64 Years and >=65 Years) achieving seroconversion is reported in the outcome measure.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 769 758
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
A/H1N1: Day 28: 60-64 Years Number Analyzed 376 participants 377 participants
66.5
(61.5 to 71.2)
41.4
(36.4 to 46.5)
A/H3N2: Day 28: 60-64 Years Number Analyzed 376 participants 377 participants
89.4
(85.8 to 92.3)
76.7
(72.1 to 80.8)
B1: Day 28: 60-64 Years Number Analyzed 377 participants 377 participants
68.2
(63.2 to 72.8)
47.7
(42.6 to 52.9)
B2: Day 28: 60-64 Years Number Analyzed 377 participants 375 participants
70.6
(65.7 to 75.1)
48.5
(43.4 to 53.7)
A/H1N1: Day 28: >=65 Years Number Analyzed 392 participants 381 participants
57.9
(52.8 to 62.8)
37.0
(32.1 to 42.1)
A/H3N2: Day 28: >=65 Years Number Analyzed 391 participants 380 participants
87.0
(83.2 to 90.1)
71.8
(67.0 to 76.3)
B1: Day 28: >=65 Years Number Analyzed 390 participants 380 participants
56.9
(51.8 to 61.9)
34.7
(30.0 to 39.8)
B2: Day 28: >=65 Years Number Analyzed 388 participants 380 participants
55.2
(50.1 to 60.2)
34.7
(30.0 to 39.8)
10.Secondary Outcome
Title Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time Frame Within 30 minutes post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set (SafAS) which included participants who had received the study vaccine and had any safety data available.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 772 761
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.3%
1
   0.1%
11.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site Reactions
Hide Description A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included induration, bruising, pain, erythema, and swelling.
Time Frame Within 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 770 759
Measure Type: Count of Participants
Unit of Measure: Participants
Bruising
12
   1.6%
7
   0.9%
Erythema
157
  20.4%
85
  11.2%
Induration
132
  17.1%
64
   8.4%
Pain
350
  45.5%
159
  20.9%
Swelling
140
  18.2%
62
   8.2%
12.Secondary Outcome
Title Number of Participants Reporting Solicited Systemic Reactions
Hide Description A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Time Frame Within 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 770 759
Measure Type: Count of Participants
Unit of Measure: Participants
Fever
18
   2.3%
4
   0.5%
Headache
184
  23.9%
141
  18.6%
Malaise
164
  21.3%
89
  11.7%
Myalgia
202
  26.2%
93
  12.3%
Shivering
128
  16.6%
54
   7.1%
13.Secondary Outcome
Title Number of Participants Reporting Unsolicited Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.
Time Frame Within 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on SafAS population.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 772 761
Measure Type: Count of Participants
Unit of Measure: Participants
190
  24.6%
172
  22.6%
14.Secondary Outcome
Title Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
Hide Description A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Time Frame From Day 0 up to 6 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS population.
Arm/Group Title Group 1: QIV-HD Group 2: QIV-SD
Hide Arm/Group Description:
Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0.
Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0.
Overall Number of Participants Analyzed 772 761
Measure Type: Count of Participants
Unit of Measure: Participants
SAE
17
   2.2%
21
   2.8%
AESI
0
   0.0%
0
   0.0%
Time Frame Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination.
Adverse Event Reporting Description Analysis was performed on safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. In the AE section, solicited reactions Shivering were reported as Chills.
 
Arm/Group Title Group 1 QIV-HD Group 2 QIV-SD
Hide Arm/Group Description Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
All-Cause Mortality
Group 1 QIV-HD Group 2 QIV-SD
Affected / at Risk (%) Affected / at Risk (%)
Total   2/772 (0.26%)      0/761 (0.00%)    
Hide Serious Adverse Events
Group 1 QIV-HD Group 2 QIV-SD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/772 (2.20%)      21/761 (2.76%)    
Cardiac disorders     
Acute Myocardial Infarction † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Coronary Artery Stenosis † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Myocardial Infarction † 1  0/772 (0.00%)  0 2/761 (0.26%)  2
Gastrointestinal disorders     
Gastric Perforation † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Intestinal Haemorrhage † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Intestinal Obstruction † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Large Intestinal Obstruction † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Rectal Haemorrhage † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Rectal Prolapse † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Infections and infestations     
Corona Virus Infection † 1  2/772 (0.26%)  2 1/761 (0.13%)  1
Pilonidal Cyst † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Pneumococcal Sepsis † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Pneumonia † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Injury, poisoning and procedural complications     
Forearm Fracture † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Humerus Fracture † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Meniscus Injury † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Road Traffic Accident † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Thermal Burn † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Metabolism and nutrition disorders     
Dehydration † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Rheumatoid Arthritis † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Tendonitis † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Bronchial Carcinoma † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Endometrial Cancer † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Polycythaemia Vera † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Thyroid Neoplasm † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Nervous system disorders     
Cerebral Thrombosis † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Cerebrovascular Accident † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Loss Of Consciousness † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Transient Ischaemic Attack † 1  1/772 (0.13%)  1 1/761 (0.13%)  1
Vith Nerve Paralysis † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Renal and urinary disorders     
Nephrolithiasis † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Urinary Incontinence † 1  0/772 (0.00%)  0 1/761 (0.13%)  1
Reproductive system and breast disorders     
Prostatitis † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
Vascular disorders     
Intermittent Claudication † 1  1/772 (0.13%)  1 0/761 (0.00%)  0
1
Term from vocabulary, MedDRA-22.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 QIV-HD Group 2 QIV-SD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   507/772 (65.67%)      354/761 (46.52%)    
General disorders     
Chills † 1 [1]  128/772 (16.58%)  130 57/761 (7.49%)  58
Injection Site Erythema † 1  157/772 (20.34%)  158 85/761 (11.17%)  85
Injection Site Induration † 1  132/772 (17.10%)  133 64/761 (8.41%)  64
Injection Site Pain † 1 [2]  350/772 (45.34%)  350 161/761 (21.16%)  161
Injection Site Swelling † 1  140/772 (18.13%)  140 62/761 (8.15%)  62
Malaise † 1 [3]  168/772 (21.76%)  168 90/761 (11.83%)  90
Musculoskeletal and connective tissue disorders     
Myalgia † 1 [4]  206/772 (26.68%)  207 94/761 (12.35%)  94
Nervous system disorders     
Headache † 1 [5]  190/772 (24.61%)  196 149/761 (19.58%)  156
1
Term from vocabulary, MedDRA-22.1
†
Indicates events were collected by systematic assessment
[1]
Chills/Shivering events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[2]
Pain events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[3]
Malaise events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[4]
Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[5]
Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi Pasteur
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT04024228    
Other Study ID Numbers: QHD00011
2019-000655-14 ( EudraCT Number )
U1111-1225-0952 ( Other Identifier: UTN )
First Submitted: July 16, 2019
First Posted: July 18, 2019
Results First Submitted: December 21, 2020
Results First Posted: January 19, 2021
Last Update Posted: April 6, 2022